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     122  0 Kommentare Allakos Reports Second Quarter 2020 Financial Results and Provides Business Update

    REDWOOD CITY, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the second quarter ended June 30, 2020 and provided an update of its ongoing development activities.

    Business Updates

    • Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 3 study of AK002 in patients with eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD). Topline data are expected in the second half of 2021.

    • Patient enrollment was initiated in a randomized, double-blind, placebo-controlled Phase 2/3 study of AK002 in patients with eosinophilic esophagitis (EoE). Topline data are expected in the second half of 2021.

    • The Phase 1 safety, tolerability and pharmacokinetics study of the subcutaneous formulation of AK002 is fully enrolled. Results are expected in the second half of 2020.

    • The non-interventional study examining the prevalence of EG, EoD, and mast cell gastrointestinal disease (MGID) in patients with chronic functional gastrointestinal disease is fully enrolled. Results are expected in the second half of 2020.

    • Announced positive clinical safety and efficacy results from a six-month, open-label Phase 1 study of AK002 in patients with MGID in March 2020.

    • Announced positive interim safety and efficacy results from the open-label, long-term extension component of the ENIGMA study with AK002 in patients with EG and/or EoD. The results were accepted for oral presentation and presented virtually at the Digestive Disease Week (DDW) Annual Meeting in May 2020.

    • The nonproprietary (generic) name of AK002 was changed from antolimab to lirentelimab as a result of trademark issues identified outside of the United States. Lirentelimab has been adopted by the United States Adopted Names (USAN) Council and World Health Organization (WHO) International Nonproprietary Names (INN) Program.

    Second Quarter 2020 Financial Results

    Research and development expenses were $28.3 million in the second quarter of 2020 as compared to $14.1 million in the same period in 2019, an increase of $14.2 million.

    General and administrative expenses were $12.1 million in the second quarter of 2020 as compared to $5.9 million in the same period in 2019, an increase of $6.2 million.

    Allakos reported a net loss of $39.3 million in the second quarter of 2020 as compared to $19.1 million in the same period in 2019, an increase of $20.2 million. Net loss per basic and diluted share was $0.80 for the second quarter of 2020 compared to $0.44 in the same period in 2019.

    Allakos ended the second quarter of 2020 with $454.9 million in cash, cash equivalents and marketable securities.

    About Allakos

    Allakos is a clinical-stage biotechnology company developing antibodies that target immunomodulatory receptors present on immune effector cells involved in allergic, inflammatory, and proliferative diseases. The Company’s lead antibody, lirentelimab (AK002), is being evaluated in a Phase 3 study in eosinophilic gastritis (EG) and/or eosinophilic duodenitis (EoD) and a Phase 2/3 study in eosinophilic esophagitis (EoE). Lirentelimab targets Siglec-8, an inhibitory receptor selectively expressed on human mast cells and eosinophils. Inappropriately activated eosinophils and mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. Lirentelimab has been tested in multiple clinical studies, in which lirentelimab eliminated blood and tissue eosinophils, inhibited mast cells and improved disease symptoms in patients with eosinophilic gastritis and/or eosinophilic duodenitis, eosinophilic esophagitis, mast cell gastrointestinal disease, severe allergic conjunctivitis, chronic urticaria and indolent systemic mastocytosis. For more information, please visit the Company's website at www.allakos.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ progress and business plans. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ early stages of clinical drug development; Allakos’ ability to timely complete clinical trials for, and if approved, commercialize lirentelimab (AK002), its lead compound; Allakos’ ability to obtain required regulatory approvals for its product candidates; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of later-stage clinical trials, regardless of the outcomes of preclinical testing and early-stage trials; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos’ ability to advance additional product candidates beyond lirentelimab (AK002); Allakos’ ability to obtain additional capital to finance its operations; and other important risk factors set forth in Allakos’ most recent Annual Report on Form 10-K filed with the SEC on February 25, 2020, Quarterly Report on Form 10-Q filed with the SEC on August 10, 2020 and future reports to be filed with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release.

    Source: Allakos Inc.


    ALLAKOS INC.
    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (in thousands, except per share data)
    (unaudited)

        Three Months Ended     Six Months Ended  
        June 30,     June 30,  
        2020     2019     2020     2019  
    Operating expenses                                
    Research and development   $ 28,346     $ 14,111     $ 46,631     $ 29,209  
    General and administrative     12,058       5,946       23,646       11,775  
    Total operating expenses     40,404       20,057       70,277       40,984  
    Loss from operations     (40,404 )     (20,057 )     (70,277 )     (40,984 )
    Interest income, net     1,284       971       3,273       2,001  
    Other income (expense), net     (172 )     14       (112 )     (42 )
    Net loss     (39,292 )     (19,072 )     (67,116 )     (39,025 )
    Unrealized gain (loss) on marketable securities, net of tax     (1,219 )     84       650       129  
    Comprehensive loss   $ (40,511 )   $ (18,988 )   $ (66,466 )   $ (38,896 )
    Net loss per common share:                                
    Basic and diluted   $ (0.80 )   $ (0.44 )   $ (1.38 )   $ (0.91 )
    Weighted-average number of common shares outstanding:                                
    Basic and diluted     48,816       43,115       48,753       42,868  


    ALLAKOS INC.
    CONDENSED BALANCE SHEETS
    (in thousands)

        June 30,     December 31,  
        2020     2019  
        (unaudited)          
    Assets                
    Current assets:                
    Cash and cash equivalents   $ 153,898     $ 38,367  
    Investments in marketable securities     301,048       457,534  
    Prepaid expenses and other current assets     3,336       3,969  
    Total current assets     458,282       499,870  
    Property and equipment, net     7,703       8,410  
    Operating lease right-of-use assets     5,633       5,775  
    Other long-term assets     2,839       2,839  
    Total assets   $ 474,457     $ 516,894  
    Liabilities and stockholders' equity                
    Current liabilities:                
    Accounts payable   $ 9,617     $ 5,963  
    Accrued expenses and other current liabilities     9,962       7,098  
    Total current liabilities     19,579       13,061  
    Other long-term liabilities     7,875       8,112  
    Total liabilities     27,454       21,173  
    Stockholders' equity:                
    Common stock     49       48  
    Additional paid-in capital     702,767       685,020  
    Accumulated other comprehensive gain     787       137  
    Accumulated deficit     (256,600 )     (189,484 )
    Total stockholders’ equity     447,003       495,721  
    Total liabilities and stockholders’ equity   $ 474,457     $ 516,894  
    CONTACT: Investor Contact:
    Adam Tomasi, President and COO
    ir@allakos.com
    
    Media Contact:
    Denise Powell
    denise@redhousecomms.com



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    Allakos Reports Second Quarter 2020 Financial Results and Provides Business Update REDWOOD CITY, Calif., Aug. 10, 2020 (GLOBE NEWSWIRE) - Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell-related diseases, today reported financial results for the …